- Job Type: Full-Time
- Function: Life Sciences R&D/Engineering
- Industry: Therapeutics
- Post Date: 09/12/2023
- Website: www.umoja-biopharma.com
- Company Address: 1920 Terry Avenue, Seattle, WA 98101, US
About Umoja Biopharma
Umoja is developing a new approach to cancer therapy that retools a patient’s immune system in vivo, enhancing the body’s natural capacity to fight cancer. We envision a world where all patients with cancer have access to the most advanced immunotherapies and are free from the burdens of traditional cancer therapies.Job Description
Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.
We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
Position Summary
This position will lead the Drug Product Development team planning and assist the Executive Director of Process and Product Development with strategy. The primary focus is delivering suitable formulations, container-closure, fill-finish processes, and in-use stability to support clinical trials with an in vivo lentiviral drug product. This will require significant cross-functional collaboration with groups such as process and analytical development, regulatory, pharm/tox and CMC teams to develop and execute drug product plans. A successful candidate should have a solid understanding of enveloped virus stability and clinical stage development.
Note: As early as September 2023 this role will work out of our new facility – the CLIMB – in Louisville, CO. The CLIMB is our Colorado Laboratory & Innovative Manufacturing Building and is located at 725 Tech Court Louisville, CO 80027.
Requirements
Specific responsibilities include:
- Serve as the drug product representative on CMC teams for Lentiviral Drug Product Programs
- Develop IND enabling drug product development plans
- Design formulation and execute formulation screening and selection
- Identify and develop stability indicating methods
- Identify primary degradation mechanisms for lentiviral drug products
- Support for QC stability study design and data analysis/interpretation
- Experimental design, execution, analysis, interpretation and presentation to multiple levels within the organization
- Support Drug Product Development strategy and life-cycle management plans
- Support Fill-finish process establishment, internal and/or external Tech-Transfer
- Work with Umoja’s legal team to capture IP regarding formulation of viral vectors
- Ability to manage a small team
The Successful Candidate Will Have
- PhD/MS/BS in molecular biology, virology, pharmaceutical science, biophysics, bioengineering or other relevant field with 8/6/2 + years of relevant experience respectively; equivalent combinations of education and experience will be considered
- Expertise in enveloped virus formulation or viral vaccine formulation, stability and container-closure system selection
- Experience with enveloped viral particle characterization methods (eg EM, NTA, SEC, AUC, DLS), cell-based titer assays and evaluation of stability indicating analytical methods
- Strong knowledge of regulatory requirements for drug product development
- Fill-finish tech transfer and/or GMP operations experience
- Regulatory document authoring experience, early phase required and late phase preferred
Preferred Qualifications
- Expertise in sub-visible particle characterization and control
- Drug product development strategy/plan creation
- Optimization of filtration processes, TFF and sterile filtration of viral vectors
- Experience with multiple routes of administration for parenterals
- Lyophilization cycle development and tech transfer
- Experience with people management
Physical Requirements
- Requires ability to perform standard viral/biological wet lab work with appropriate PPE
- Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working with your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
Salary Range: $125,375 - $169,625
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans through Premera Blue Cross, Delta Dental, and VSP. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive, unlimited Paid Time Off policy, employee commuter benefits, and childcare reimbursement. For a full breakdown of our benefits offerings, please see the Benefits section of our website.